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ISOSORBIDE MONONITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RICONPHARMA LLC · Approved 2018-11-05

Drug application

FDA Application #

ANDA210918

Application type

Abbreviated New Drug Application (Generic)

Brand name

ISOSORBIDE MONONITRATE

Generic name

ISOSORBIDE MONONITRATE

Active ingredients

ISOSORBIDE MONONITRATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

RICONPHARMA LLC

Manufacturer

Ingenus Pharmaceuticals, LLC

First approval

2018-11-05

Source

Authoritative

Drugs@FDA application overview

Machine

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